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BronchiectasisPhase 3BATNCT00415350

Bronchiectasis and Long Term Azithromycin Treatment

A Phase 3 study testing Azithromycin in people with Bronchiectasis and Inflammation, run by W.G.Boersma at 16 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

1. SUMMARY Rationale: Patients with bronchiectasis often experience lower respiratory tract infections with progression of symptoms and decline in quality of life. Macrolides, as has been shown in panbronchiolitis and cystic fibrosis, may break or weaken the link between infection and inflammation resulting in an… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Bronchiectasis, Inflammation
What is being tested?
Azithromycin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
16 sitesNetherlands
Study dates
Apr 2008to Dec 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients aged 18 ≥ years
  • Bronchiectasis diagnosed by plain bronchography or high resolution computer tomography.
  • Minimal 3 lower respiratory tract infections (LRTI) treated with oral/intravenous (IV) antibiotics in the year preceding the study inclusion.
  • The presence of chronic respiratory symptoms such as cough, dyspnoea, expectoration of sputum.
  • At least one positive sputum culture in the preceding year.
  • Informed consent

Who cannot join

  • Previous ( ≥ 4 weeks) prolonged macrolide therapy.
  • Pregnant or lactating women.
  • Allergy to macrolides.
  • Intolerance to macrolides.
  • Liver disease (alanine transaminase and/or aspartate transaminase levels 2 or more times the upper limit of normal).
  • Use of antibiotics within 14 days of screening.
  • Use of oral or IV corticosteroids (≥ 30 mg prednisolone/daily) within 30 days of screening.
  • Other research medication started 2 months prior to inclusion.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Netherlands16 sites

  • Alkmaar Medical Center

    Alkmaar, N-H, 1800AM

  • AMC

    Amsterdam

  • St Lucas Andreas Ziekenhuis

    Amsterdam

  • Rode Kruis Ziekenhuis

    Beverwijk

  • Deventer Ziekenhuis

    Deventer

  • U.L.C. Dekkerswald

    Groesbeek

  • University Hospital Groningen (UMCG)

    Groningen

  • Atrium Medisch Centrum

    Heerlen

  • Tergooi Ziekenhuizen

    Hilversum

  • Spaarne Ziekenhuis

    Hoofddorp

  • MC Leeuwarden

    Leeuwarden

  • Antonius Ziekenhuis

    Nieuwegein

  • Erasmus Medical Center

    Rotterdam

  • Diakonessenhuis

    Utrecht

  • Viecuri MC

    Venlo

  • Isala Klinieken

    Zwolle

Other trials in Netherlands

About this study

Official title: Bronchiectasis and Long Term Azithromycin Treatment: A Randomised Placebo-controlled Trial Studying Disease Modifying Effects of Immunomodulating Treatment

  1. SUMMARY

Rationale: Patients with bronchiectasis often experience lower respiratory tract infections with progression of symptoms and decline in quality of life. Macrolides, as has been shown in panbronchiolitis and cystic fibrosis, may break or weaken the link between infection and inflammation resulting in an improvement of symptoms. Also the number of exacerbations may lowered.

Read more

Objective: A reduction in number of infective exacerbations and improvement in lung function by AZT treatment are the primary objectives. Secondary objectives that will be evaluated are: symptoms score, quality of life, inflammatory parameters, bacterial colonisation, and adverse events.

Study design: Randomised double blind multicenter study in the Netherlands. Patients will be stratified for colonisation with P.aeruginosa.

Study population: Patients with bronchiectasis demonstrated by high-resolution computed tomography (HR-CT) scan or bronchography.

Intervention: Patients receive Azithromycin 250mg(p.o.) once daily or placebo.

Main study parameters/endpoints: Reduction in number exacerbations, defined as increase symptoms such as dyspnoea, coughing, and sputum production for which a course of prednisolone and/or antibiotic is needed. Change in lung function parameters (forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC]) measured by spirometry is the other primary endpoint.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risk of participating in this study is low. Laboratory, radiographic examinations, and pulmonary function tests are commonly used as diagnostic procedures during outpatients visits and during exacerbations. Adverse effects in maintenance treatment with AZT are usually mild and mainly gastrointestinal. Sometimes rash and abnormal liver function tests are observed. A better quality of life will probably be the beneficial effect of long term treatment with AZT. This will be achieved by a reduction in respiratory and non-respiratory symptoms and number of exacerbations.

Being tested
Azithromycin, Placebo
Keywords
Bronchiectasis, Macrolide, Azithromycin, Antibiotic prophylaxis, Immunomodulation, Inflammation, Lung function, Sputum, Bacterial colonization
Medical subject headings
Bronchiectasis, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AzithromycinDrug

    Azithromycin Tablet 250 mg daily

  • PlaceboOther

    Placebo tablet 1 daily

Study groups in NCT00415350
Study groupRoleWhat they receive
Azithromycin treatment 1Active comparatorNot described
Receives: Drug: Azithromycin
Placebo 2Placebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis?

    Measured: 1 year

  2. Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )?

    Measured: 1 year

Secondary outcomes (5)

  1. Is there any improvement in symptom score during treatment with AZM?

    Measured: 1 year

  2. What is the effect of AZM on bacterial colonisation?

    Measured: 1 year

  3. Does treatment with AZM reduce inflammatory parameters?

    Measured: 1 year

  4. Does treatment with AZM change the quality of life?

    Measured: 1 year

  5. Is there any differences in adverse events between AZM and placebo treatment?

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2006 (estimated)
  2. Study startApr 2008
  3. Primary completionDec 2009
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00415350
Sponsor's protocol ID
BAT-2006-MCA1
Other IDs
BAT-2006
Acronym
BAT
Status last verified
May 2020
First submitted
21 Dec 2006
Last updated
28 May 2020
Results posted
No
Data monitoring committee
No

Publications

  • Terpstra LC, Altenburg J, Mohamed Hoesein FA, Bronsveld I, Go S, van Rijn PAC, De Jong PA, Heijerman HGM, Boersma WG. The effect of maintenance azithromycin on radiological features in patients with bronchiectasis - Analysis from the BAT randomized controlled trial. Respir Med. 2022 Feb;192:106718. doi: 10.1016/j.rmed.2021.106718. Epub 2021 Dec 28.

    PubMed 34974413

  • Altenburg J, de Graaff CS, Stienstra Y, Sloos JH, van Haren EH, Koppers RJ, van der Werf TS, Boersma WG. Effect of azithromycin maintenance treatment on infectious exacerbations among patients with non-cystic fibrosis bronchiectasis: the BAT randomized controlled trial. JAMA. 2013 Mar 27;309(12):1251-9. doi: 10.1001/jama.2013.1937.

    PubMed 23532241

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Azithromycin in people with Bronchiectasis and Inflammation, run by W.G.Boersma at 16 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis? (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00415350, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020; AzTrials last refreshed its copy on 27 Oct 2026.

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